Reviderm Ag
⚠️ Moderate Risk
FEI: 3004504938 • Oberhaching, Bavaria • GERMANY
FEI Number
3004504938
Location
Oberhaching, Bavaria
Country
GERMANYAddress
Linienstr. 1, , Oberhaching, Bavaria, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/4/2019 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 9/9/2013 | 65GBL99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/30/2012 | 62SDL99ANTI-SEBORRHEIC N.E.C. | Detroit District Office (DET-DO) | |
| 6/29/2006 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Reviderm Ag's FDA import refusal history?
Reviderm Ag (FEI: 3004504938) has 5 FDA import refusal record(s) in our database, spanning from 6/29/2006 to 10/31/2019.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Reviderm Ag's FEI number is 3004504938.
What types of violations has Reviderm Ag received?
Reviderm Ag has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Reviderm Ag come from?
All FDA import refusal data for Reviderm Ag is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.